| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00893-1 |
| Product Name/Description |
TOPPER Xtra Absorbent Dressing Pads, Sterile
Product codes: P55263 and P55264 – all pack sizes
All lots affected
ARTG number: 168750 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Systagenix has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised to discontinue use of affected stock and monitor any patients who are using, or have recently used, any of the affected products for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. If symptoms are presented then the clinician should treat appropriately. This action has been closed-out on 1/06/2016. |
| Contact Information |
1300 524 822 - KCI Customer Service |